FDA 510(k)

MagDI系統（MAG-02，DS-01）

K 號：K243359 · 2025-02-28

決定日期2025-02-28

產品代碼SAH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

MagDI System (MAG-02, DS-01) is the device name listed in this FDA 510(k) record. The listed applicant is Gt Metabolic Solutions, Inc.. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K243359. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MagDI System (MAG-02, DS-01)?

MagDI System (MAG-02, DS-01) is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Gt Metabolic Solutions, Inc.. The 510(k) number is K243359.

When did MagDI System (MAG-02, DS-01) receive FDA 510(k) clearance?

MagDI System (MAG-02, DS-01) received FDA 510(k) clearance on 2025-02-28, under 510(k) number K243359.

Who is the listed applicant for MagDI System (MAG-02, DS-01)?

FDA 510(k) 記錄將 Gt Metabolic Solutions, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for MagDI System (MAG-02, DS-01)?

The FDA product code for MagDI System (MAG-02, DS-01) is SAH.

其他以 Gt Metabolic Solutions, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261467GT代謝磁鐵系統（MAG-04，DS-01）GT代謝磁鐵系統（MAG-05，DS-01）K253102GT代謝磁力DI系統（MAG-01、MAG-02、DS-01）K242086MagDI系統（MAG-01，DS-01）

相關器械（代碼：SAH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261467GT代謝磁鐵系統（MAG-04，DS-01）GT代謝磁鐵系統（MAG-05，DS-01）Gt Metabolic Solutions, Inc.K253102GT代謝磁力DI系統（MAG-01、MAG-02、DS-01）Gt Metabolic Solutions, Inc.K253550自成型磁鐵（Flexagon Plus OTOLoc）GI Windows, Inc.K250541自成型磁鐵（Flexagon Plus OTOLoc）GI Windows, Inc.K243482自成型磁鐵（Flexagon）GI Windows, Inc.K243213自形成磁鐵（FLEX SFM）GI Windows, Inc.

官方來源

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